Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities

Phase 1CompletedNCT05619211

University of Alabama at Birmingham42 enrolled

Overview

This study is investigating the potential effects of a high-intensity home-exercise program among children with cerebral palsy. The program includes rhythmic movements to music that are adapted for wheelchair uses and age-appropriate themes. This project has the potential to address a large knowledge gap in the extant literature, because there are no widely accessible, evidence-based, enjoyable, and age-appropriate modalities for improving cardiovascular fitness or cardiometabolic health among children with disabilities who have mobility disabilities.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy

Interventions

Sprint-Intensity Interval Training with Telecoaching

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

We are recruiting 50 parent-child dyads. Childs are the participant undergoing the exercise intervention. Parents are required to support the safety and schedule of the child participant. Parents are considered participants due to their responsibilities. Inclusion Criteria: * have a medical diagnosis of cerebral palsy, as determined by ICD-10 codes * aged 6-17 years old * a Gross Motor Function Classification System Level I-IV (as determined via participant screening, explained in the protocol section below) * medical clearance to participate in high-intensity exercise from a physician (using the attached medical screening form and explained in the intervention safety, monitoring, and response plan) * access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer * a caregiver who will support and monitor the participant's safety during the intervention and manage the child's exercise schedule. Exclusion Criteria: * physically active (defined as \>150 minutes per week of self-reported moderate-to-vigorous intensity exercise in a typical week) * cannot use their arms for exercise * a Gross Motor Function Classification Level of V * complete blindness or deafness; * Any past history of a contraindication to exercise testing according to American College of Sports Medicine (ACSM) guidelines (Liguori and American College of Sports Medicine, 2020): significant change in the resting electrocardiogram suggesting significant ischemia, myocardial infarction, or other cardiac event, unstable angina, uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, pulmonary embolus or pulmonary infarction, myocarditis or pericarditis, aneurysm. * pregnant (due to radiation from a Dual Energy X-ray Absorptiometry \[DEXA\] scan) * has not been seen by a physician within the last year * uses a g-tube Eligible caregivers will include parents or legal guardians of the child, who can commit sufficient time to support the child in their roles for the study and communicate in English. Caregivers who have complete blindness or deafness will be excluded from participation.

Outcomes

Primary Outcomes

Changes in pVO2

peak oxygen consumption (mL/kg-1/min-1) obtained from a graded exercise test on an arm ergometer. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Secondary Outcomes

Change in Body Weight

body weight in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Total Body Fat

body fat in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Total Lean Mass

lean mass in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Lean Tissue Percentage

percentage of lean tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Fat Tissue Percentage

percentage of fat tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in C-reactive Protein

hsCRP (mg/L) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Hemoglobin A1C

HbA1C (mmol/mol) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Fasting Insulin

Fasting Insulin (μIU/mL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Fasting Triglycerides

Fasting Triglycerides (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Fasting High-density Lipoprotein

HDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Fasting Low-density Lipoprotein

LDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Systolic Blood Pressure

systolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Changes in Diastolic Blood Pressure

diastolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant.

Time frame: Week 0, Week 13

Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes